C. Key Issues Presented by Interested Parties and Discussed by the DUR Board during the Public Comment Period:

Cyclosporine Ophthalmic Emulsion

The Board was asked to consider information regarding utilization data and surveys, with regard to the indication of keratoconjunctivitis sicca (KCS), and addressing the underlying pathophysiology of dry eye.

Quinine

Dr. Coe and Dr. Doloresco presented the quinine utilization review. The Board was informed of the sole FDA approved indication for quinine, which is for the treatment of malaria, as well as public health concerns and the FDA black box warning associated with the risk of serious life-threatening adverse events including death. Also included was FDA data subsequent to the black box warning that showed the majority of the adverse events related to quinine were associated with non-approved use. The Board was also provided with NYS Medicaid claims utilization information related to potential overutilization or misuse. Prior authorization requirements from comparator state Medicaid programs were also reviewed.

Cyclosporine Ophthalmic Emulsion

Dr. Wrobel and Dr. Doloresco presented the Board with a review of ophthalmic cyclosporine emulsion (Restasis) with regards to findings in the 2007 Dry Eye Workshop (DEWS) report outlining data with regards to proper progression of therapy from artificial tears to ophthalmic cyclosporine emulsion when used for dry eyes. The Board reviewed NYS Medicaid claims data that showed a large percentage of ophthalmic cyclosporine emulsion utilization without a prior claim for artificial tears. The Board was also provided with information on prior authorization requirements from comparator state Medicaid programs.

Buprenorphine and Buprenorphine/Naloxone Sublingual Tablets

Dr. Wrobel and Dr. Doloresco presented the DUR Board information regarding buprenorphine and buprenorphine/naloxone sublingual tablets including indications, adverse events, information regarding dosing and administration, and potentially fatal drug interactions. The Board was provided information from national and international sources regarding the abuse and diversion of these medications. The Board was also provided with NYS Medicaid claims utilization information specifically related to potential overutilization or misuse. Prior authorization requirements from comparator state Medicaid programs were also reviewed.

Triptans

Dr. Coe presented the DUR Board with information regarding triptans including indications, adverse events, efficacy and safety, and information regarding dosing and administration. The Board was provided with an overview of the The European Federation of Neurological Societies (EFNS) 2009 guidelines that clarify appropriate triptans use. Overuse of triptans and the associated dangers were also discussed. Dispensing limitations in comparator state Medicaid programs were also reviewed.

New York State Medicaid Utilization Thresholds

Ms. Shields presented the New York State Medicaid Utilization Thresholds overview. The DUR Board was provided information on the modernization of the thresholds, the impact of the modernization, and next steps. The Board was also provided a monthly breakdown on overrides and communications.

Prescriber Education Program (PEP)

Ms. Morris and Dr. Lehmann presented an update on the Prescriber Education Program (PEP) to the DUR Board. The DUR Board was provided with a detailed description the PEP. Points of discussion included identification of topics, processing topics, module development, and current modules that have been implemented and modules still in development.

Medication Therapy Management (MTM)

Ms. Morris presented an update on the Medication Therapy Management (MTM) program to the DUR Board. Points of discussion focused on the potential synergy between the Prescriber Education Program and MTM.

E. DUR Board Discussion

The DUR Board discussed utilization of clinically comparable topical corticosteroids including indications for use and the cost effectiveness of generic products of comparable potencies within this class of drugs.

The DUR Board discussed utilization of clinically comparable topical antifungals including indications for use and the cost effectiveness of OTC/generic products in the drug class.

The DUR Board discussed utilization of clinically comparable ophthalmic non-fluoroquinolone antibiotics and ophthalmic antibiotic/steroid combinations including indications for use and the cost effectiveness of generic products in these drug classes.

The DUR Board discussed the use of montelukast in non-asthmatic patients with allergic rhinitis in relation to the first line use of equally effective and more cost effective OTC and prescription antihistamines. Discussion also included the use of more cost effective intranasal corticosteroid products and their greater efficacy in treating allergic rhinitis in the absence of asthma.

The DUR Board discussed the high utilization and frequency of use of triptans and potential adverse effects patients may incur.

The DUR Board discussed quinine with regards to quantity/frequency/duration limits and inclusion in the Clinical Drug Review Program (CDRP). The discussion focused on the black box warning concerning the increased rate of serious life-threatening adverse events and the utilization of the product in non-approved and clinically unsupported indications.

The DUR Board discussed ophthalmic cyclosporine emulsion with regards to step therapy and quantity limits. The discussion focused on utilization of the product for dry eyes in place of artificial tears, including recent recommendations for a trial of artificial tears therapy before cyclosporine, and that artificial tears are proven both clinically safe and effective at a lower cost. The board also deliberated the necessity of a trial of two artificial tear preparations versus one preparation.

The DUR Board discussed concerns over the increased utilization of buprenorphine and buprenorphine/naloxone sublingual tablets with regards to high doses and pain management. The focus of discussion was on the pharmacology of partial agonists when used in pain management and appropriate dosing based on FDA labeling and published opioid dependence treatment guidelines.

The DUR Board discussed oxycodone controlled release tablets in the context of non-cancer diagnoses. The discussion focused on overutilization and potential misuse of this drug. The Board discussed quantity limits based on black box warnings for the abuse liability of these products and the overutilization of the 60mg and 80mg tablets. Also discussed was the dose optimization of the lower strengths of oxycodone controlled release tablets.

F. DUR Board Action:

Topical Corticosteroids

The DUR Board took the following actions regarding topical corticosteroids:

Step therapy will be applied for topical corticosteroids to ensure appropriate utilization and cost effectiveness.

Prior authorization would be required for single source and multisource brand name topical corticosteroids if there is no prior paid claims history of an over the counter (OTC) or generic formulation of comparable potency first.

The following prior authorization question would be asked when single source and multisource brand topical corticosteroids are being prescribed prior to utilizing an OTC or generic formulation of comparable potency first.

What is the clinical rationale that would require utilization of a single source or multi source brand prior to prescribing a more cost effective medication of comparable potency for this patient?

Topical Anti-Fungals

The DUR Board took the following actions regarding topical anti-fungals:

Step therapy will be applied for topical anti-fungals to ensure appropriate utilization and cost effectiveness.

Prior authorization would be required for single source and multisource brand name topical anti-fungals if there is no prior paid claims history of an over the counter (OTC) or generic formulation of comparable coverage first.

The following prior authorization question would be asked when single source and multisource brand topical anti-fungals are being prescribed prior to utilizing an OTC or generic formulation of comparable coverage first.

What is the clinical rationale that would require utilization of a single source or multi source brand prior to prescribing a more cost effective medication of comparable coverage for this patient?

The DUR Board took the following actions regarding antibiotics and antibiotic/steroid combinations:

Step therapy will be applied for antibiotics and antibiotic/steroid combinations to ensure appropriate utilization and cost effective therapy.

Prior authorization would be required for select single source and multisource brand ophthalmic antibiotics and antibiotic/steroid combinations if the patient has not attempted to use a more cost effective formulation of comparable coverage first.

The following prior authorization question would be asked when select single source and multisource brand antibiotics or antibiotic/steroid combinations are being prescribed prior to attempting to use a more cost effective formulation of comparable coverage.

What is the clinical rationale that would require utilization of a single source or multi source brand prior to prescribing a more cost effective medication of comparable coverage for this patient?

Montelukast

The DUR Board took the following actions regarding montelukast:

Step therapy will be applied for montelukast in non-asthmatic patients for the treatment of allergic rhinitis.

Prior authorization would be required for montelukast if there is no prior paid claims history of an intranasal corticosteroid or oral antihistamine.

The following prior authorization questions would be asked for montelukast if there is no prior paid claims history of an intranasal corticosteroid or oral antihistamine.

Is montelukast being prescribed for an individual with asthma or a history of asthma?

If montelukast is being prescribed for allergic rhinitis, what is the clinical rationale that would require utilization of montelukast over an intranasal corticosteroid or oral antihistamine?

Triptans

The DUR Board took the following actions regarding triptans:

Quantity and frequency limits will be applied to triptans to ensure appropriate utilization.

The limits will be based on FDA approved labeling for indications, dosing and administration, and EFNS guidelines of treating nine headaches per month.

Limit of 18 intranasal or oral dosage units per month, or the equivalent of 9 days at the recommended dose, as appropriate.

The following prior authorization question would be asked when the limits are exceeded:

What is the clinical rationale justifying use greater than that supported by FDA approved labeling?

Quinine

The DUR Board took the following actions regarding quinine:

Quantity and frequency limits will be applied to quinine to ensure appropriate utilization.

The limits will be based on FDA approved labeling for the treatment of malaria and low rates of incidence as reported by the CDC.

A maximum of 42 capsules for a 7 day supply, and limit of 1 prescription per year.

The following prior authorization question will be asked when the limits are exceeded:

What is the clinical rationale that would justify use greater than that supported by FDA approved labeling?

The Board also agreed that quinine meets the criteria for inclusion into the CDRP.

Cyclosporine Ophthalmic Emulsion

The DUR Board took the following actions regarding cyclosporine ophthalmic emulsion:

Step therapy and quantity limitations will be applied for cyclosporine ophthalmic emulsion to ensure appropriate utilization and cost effectiveness.

Prior authorization would be required for cyclosporine ophthalmic emulsion for patients without a documented diagnosis that justifies first line utilization with no prior paid claims history of an artificial tear/gel/ointment.

The following prior authorization question would be asked when patients have not first attempted an artificial tear/gel/ointment:

What is the clinical rationale that would require utilization of cyclosporine ophthalmic emulsion prior to use of an artificial tear/gel/ointment?

Quantity limits are based on FDA approved labeling for indications, dosing and administration.

A maximum of 60 vials (2 trays) for a 30 day supply.

The following prior authorization question would be asked when the limits are exceeded:

What is the clinical rationale that would justify use greater than that supported by FDA approved labeling?

Buprenorphine and Buprenorphine/Naloxone

The DUR Board took the following actions regarding buprenorphine and buprenorphine/naloxone sublingual tablets:

Quantity and frequency limits to ensure appropriate utilization based on FDA approved labeling for indications, dosing and administration, and guidelines for treating opioid dependency.

A quantity/duration limit on buprenorphine sublingual tablets with a maximum of 6 tablets for a 2 day supply.

A maximum of 3 buprenorphine/naloxone sublingual tablets daily with an upper limit of 90 tablets for a 30 day supply.

The following prior authorization question would be asked when the limits are exceeded:

For buprenorphine sublingual tablets: What is the clinical rationale that would justify greater than a) 3 tablets daily or b) 2 days supply?

For buprenorphine/naloxone sublingual tablets: What is the clinical rationale that would justify greater than 3 tablets daily?

Oxycodone Controlled Release

The DUR Board took the following actions regarding oxycodone controlled release:

Quantity and frequency limits for patients without a documented cancer diagnosis, to ensure appropriate utilization based on FDA approved labeling for indications, warnings, and dosing and administration.

A quantity limit of 60 tablets per strength every 30 days not to exceed a daily dose of 160mg for oxycodone controlled release tablets.

The following prior authorization question would be asked when the limits are exceeded:

For oxycodone controlled release tablets: What is the clinical rationale that would justify a daily dose greater than a) 160mg or b) 2 tablets (60 tablets per 30 days)?